(29 days)
This device is intended for use by qualified personnel in the Doctor's Office, Operating Room and Nursing Station. The Advanced Image and Data Archiving Compact II System (AIDA Compact II) is a Windows based archiving and documentation station. It allows capture and annotation of video sequences and patient data recording during a diagnostic or therapeutic procedure. It allows capture and annotation of the surgical procedure for documentation purposes. Images captured and distributed by AIDA are for viewing and reference purposes and are not intended for primary diagnosis.
It offers an optional Windows® based solution to communicate with other picture archival communication systems (PACS) using DICOM and with Hospital Information Systems (HIS) using the HL7 standard. Also as a part of the AIDA Compact II System, the Storz Application Manager software (SAM) enables the selection and integration of AIDA with the Storz Communication Bus (SCB) or other third party image capturing devices.
The Advanced Image and Data Archiving Compact II System (AIDA Compact II) is a Windows based archiving and documentation station. It allows capture and annotation of video sequences and patient data recording during a diagnostic or therapeutic procedure. It allows capture and annotation of the surgical procedure for documentation purposes. Images captured and distributed by AIDA are for viewing and reference purposes and are not intended for primary diagnosis. It offers an optional Windows® based solution to communicate with other picture archival communication systems (PACS) using DICOM and with Hospital Information Systems (HIS) using the HL7 standard. Also as a part of the AIDA Compact II System, the Storz Application Manager software (SAM) enables the selection and integration of AIDA with the Storz Communication Bus (SCB) or other third party image capturing devices.
This document is a 510(k) clearance letter from the FDA for the AIDA Compact II device. It does not contain information about the device's acceptance criteria or any study details. The letter states that the device is a "Picture archiving and communications system" and is intended for use in recording and archiving image sequences and patient data during diagnostic or therapeutic procedures for viewing and reference purposes, not for primary diagnosis.
Therefore, I cannot provide details on the acceptance criteria or study that proves the device meets them based on the provided text. The document's purpose is to grant market clearance, not to detail the technical validation of the device.
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Public Health Service
SEP - 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Paul Lee Senior Regulatory Affairs Specialist Karl Storz Endoscopy America, Inc. 600 Corporate Point 5th Floor CULVER CITY CA 90230-7600
Re: K052159
Trade/Device Name: AIDA Compact II Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: LLZ Dated: August 9, 2005 Received: August 16, 2005
Dear Mr. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been rear 20, 1970, accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the do not require to the general controls provisions of the Act. The general controls provisions of the Act as not a requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket) n your al), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k)
10 Jegal This letter will allow you to ocgin hanceing your intribution of your device to a legally premarket notification. The FDA midnig of Sacsamian or your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device of our laboring numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to prematet notification" (21 CFR Also, please note the regulation entitled, "First in a so a responsibilities under the Act from the 807.97). You may obtain other gelleral informational and Consumer Assistance at its toll-free number (800) Division of Binal J. Binal its Internet address 050 2011 01 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Koszisq
Device Name: AIDA Compact II
Indications for Use: This device is intended for use by qualified personnel in the Indications for Ose. This device 13 million Station. The Advanced Image and Data Doctor's Office, Operating Room and Natoes of II) is a Windows based archiving and Archiving Compact II System (AIDA Compact in a lio sequences and patient data recording during a diagnostic or therapeutic procedure. It allows capture and annotation recording during a diagnostic or therapeans proved. Images captured and distributed by of the surgical procedure for documemation parposes mange of I
AIDA are for viewing and reference purposes and are not intended for primary diagnosis.
It offers an optional Windows® based solution to communicate with other picture archival It offers an optional willidows "based solution to with Hospital Information Systems communication systems (1 ACO) using Dress a part of the AIDA Compact II System, the Storz
(HIS) using the HL7 standard. Also as a part of the AIDA comparism of AIDA (HIS) using the HL 7 standard. Also as a part of the selection and integration of AIDA
Application Manager software (SAM) enables the selection and integration Ba Application Manager Sortware (Drive) Shaolor and Corner Communication Bus (SCB) or other third party image capturing devices.
Over-The-Counter Use: ______________________________________________________________________________________________________________________________________________________________________________ Prescription Use: (21 CFR 801 Subpart C) (Per 21 CFR 801.Subpart D) .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ASE DO NOT WRITE BELOW THIS LIND - OONTHIOD OF ATTING OF PARTIC
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices 12052159
510(k) Number _
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).